Kornimate/medical-research-clean huggingface dataset:
mobile phone based intervention to protect mental health in healthcare workers at frontline against covid19

Conditions: Mental Health Disorder; Depression; Posttraumatic Stress Disorder; Burnout; Anxiety Disorders

Summary: this study aims at evaluating the effectiveness of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against covid-19 in spain. the intervention will consist in psychoeducation, delivered via a mobile app. participants will be followed up during two weeks. the primary outcome will be symptomatology of depression, anxiety or stress.

healthcare workers (hcws) commonly present high levels of anxiety, depression, posttraumatic stress, acute disorder and burnout, both during and after viral outbreaks. although educational and multifaceted interventions might mitigate the development of mental health problems, the certainty on the evidence is very low. the aim of this double-blinded randomized clinical trial is to examine the impact of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against covid-19 in spain. the trial will include hcws having provided healthcare to patients with covid19 in a healthcare centre (any setting) in spain during the viral outbreak in spain. professionals from any medical speciality and role (doctors, nurses, nurse assistance, etc.) with access to a smartphone will be included. the investigators will collect expressions of interest via dissemination of the study through social media and key stakeholders (hospital managers, scientific societies and professional colleges). a team of psychologists will contact (via telephone) potential participants to confirm they meet the eligibility criteria (described above), obtain signed consent (audio-recorded), and carry out a psychological (pre-intervention) evaluation. the participants will then be randomly allocated to receive a fully functional app (full intervention) or an app with brief generic recommendations about mental health (control intervention). a post-intervention psychological assessment will be undertaken after two weeks. the primary outcome will be symptomatology of depression, anxiety or stress. secondary outcomes will include posttraumatic stress, burnout, insomnia, and self-efficacy. after the two weeks follow-up, all participants allocated to the control intervention will be offered the full intervention.

Eligibility criteria:
inclusion criteria: healthcare workers having provided healthcare to patients with covid19 in a healthcare centre (any setting) during the viral outbreak in spain. we will include professionals from any medical speciality and role (doctors, nurses, nurse assistance, etc.). exclusion criteria: we will exclude healthcare workers not able to use, or with no access, to a smartphone.
fat distribution in healthy early postmenopausal women

Conditions: Healthy; Postmenopause

Summary: the aim of this study is to explore the effects of hormone replacement therapy with ev/dng on abdominal fat distribution measured by magnetic resonance imaging.

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer schering pharma ag, germany.bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * healthy early postmenopausal women * bmi between 25 and 30 exclusion criteria: * contra-indication(s) for hormone treatment * metabolic diseases * concomitant medication with influence on lipid metabolism

Keywords: early postmenopausal state climacteric symptoms hormone replacement therapy
predicting antipsychotic discontinuation in psychosis

Conditions: Schizophrenia

Summary: the purpose of this study is to determine whether dopamine synthesis capacity by using \[18 fluorine(f)\]-dopa pet for patients with schizophrenia in the maintenance phase can predict treatment discontinuation.

there are two groups: the healthy control group (n=12) and the patient group (n=26). the patient group recruits subjects diagnosed with first episode psychosis which occurred within 2 years and having been treated with antipsychotics for 1 year. participants will complete clinical scales and undergo pet scans. subjects in the patient group will receive a reduced intake of antipsychotics by 25% after each week of the four-week period in which they will also undergo pet imaging at the baseline, 7 week, and 8 week marks to detect the correlation between the capacity of presynaptic dopamine and relapse in the patients discontinuing treatment.

Eligibility criteria:
inclusion criteria: 1. patient group 1. patients who met dsm-iv criteria for schizophrenia, schizoaffective disorder, and schizophreniform disorder 2. patients diagnosed with first episode psychosis which occurred within 2 years and having been treated with antipsychotics for at least 1 year. 3. patients who have maintained in the stable state for 3 months without medication change at the baseline. 2. healthy control group * healthy controls has no axis i disorder and do not report any past event of neurological or psychiatric illness assessed by the structured clinical interview for dsm disorders exclusion criteria: 1. participants should not have any neurological illness such as head trauma, seizure and meningitis. 2. participants should not be diagnosed as mental retardation(iq\<70) 3. participants should not have severe personality disorder, substance abuse or dependence (except for nicotine abuse and dependence) and severe medical conditions.

Keywords: dopamine receptor occupancy antipsychotics positron emission tomography
a study of the safety, efficacy, and biomarker response of bms-986165 in participants with moderate to severe ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of bms-986165 administered orally in participants with moderate to severe ulcerative colitis. the study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. after the initial 12-week period, all subjects receive active therapy (open-label extension). with protocol amendment 2, one of the dose treatment arms is being removed from the 12-week double blind period with no change to the open-label extension.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ulcerative colitis (uc) at least 3 months' duration prior to screening * moderately to severely active uc as assessed by the modified mayo score * documentation of an inadequate response, loss of response, or intolerance to a treatment course of 1 or more of the following standard of care medications: oral 5-aminosalicylic acids, corticosteroids, immunomodulators, anti-tumor necrosis factor (tnf) agents, integrin inhibitors\[sa1\] * documentation of prior treatment with corticosteroids for ≥ 4 weeks * males and females must agree to follow specific methods of contraception, if applicable exclusion criteria: * current diagnosis of crohn's disease (cd) or diagnosis of indeterminate colitis (ic), ischemic colitis, or pseudomembranous colitis * current evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation * history or evidence of any extensive colonic resection, or subtotal or total colectomy * women who are pregnant or breastfeeding * prior exposure to bms-986165 or a tyrosine kinase 2 (tyk2) inhibitor other protocol-defined inclusion/exclusion criteria apply.
depsipeptide in treating patients with solid tumors

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of depsipeptide in treating patients who have solid tumors for which no standard therapy exists.

objectives: i. determine the toxic effects and the maximum tolerated dose (mtd) of depsipeptide in patients with incurable solid tumors (per 3/29/00 notification, only patients with cutaneous t-cell lymphoma are being accrued). ii. determine antineoplastic activity of depsipeptide in these patients. outline: this is a dose escalation, multicenter study. patients receive depsipeptide iv over 4 hours on days 1 and 5. treatment continues every 21 days in the absences of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of depsipeptide. if 2 of 6 patients experience dose-limiting toxicity at a given dose level, escalation ceases and the maximum tolerated dose is defined as the previous dose level . projected accrual: a maximum of 48 patients will be accrued for this study within 18-24 months.

Eligibility criteria:
disease characteristics: histologically confirmed incurable solid tumor (per 3/29/00 notification, only patients with cutaneous t-cell lymphoma are being accrued) no known standard therapy for the disease that is potentially curative or definitely capable of extending life expectancy no cns metastases patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: greater than 12 weeks hematopoietic: wbc greater than 3,500/mm3 platelet count greater than 100,000/mm3 pt/ptt no greater than 1.1 times upper limit of normal (uln) hepatic: bilirubin less than 1.5 uln ast less than 3 times uln renal: creatinine less than 1.5 times uln cardiovascular: cardiogram must be performed within 1 month of protocol registration no class iii/iv heart disease ejection fraction of at least 45% by muga or echo other: hiv negative no recent weight loss of greater than 10% of average body weight oral intake of at least 1,200 calories/day no uncontrolled infection not pregnant or nursing fertile patients must use effective contraception no serious concurrent illness such as seizure disorder, uncontrolled hypertension, or myelodysplastic syndrome prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) no prior doxorubicin of a total dose greater than 360 mg/m2 endocrine therapy: not specified radiotherapy: at least 3 weeks since prior radiation therapy with depsipeptide no prior radiation to greater than 25% of bone marrow surgery: at least 21 days since prior major surgery

Keywords: stage iii cutaneous t-cell non-hodgkin lymphoma stage iv cutaneous t-cell non-hodgkin lymphoma recurrent cutaneous t-cell non-hodgkin lymphoma stage iii mycosis fungoides/sezary syndrome stage iv mycosis fungoides/sezary syndrome recurrent mycosis fungoides/sezary syndrome
acupuncture for obesity with prediabetes

Conditions: Obesity; Pre-diabetes

Summary: the clinical trial aims to evaluate the efficacy and safety of acupuncture on weight loss and changes of glucose and lipid metabolism in obese adults with pre-diabetes.


Eligibility criteria:
inclusion criteria: - subjects are eligible to be included in the trial only if all of the following criteria apply: 1. meet the diagnostic criteria of obesity and pre-diabetes; 2. aged 18-64 years old; 3. informed consent obtained before any trial-related activities. exclusion criteria: - subjects are excluded from the trial if any of the following criteria apply: 1. obesity of known endocrine origin (e.g., untreated hypothyroidism, cushing's syndrome, established polycystic ovary syndrome); 2. impaired glucose regulation due to hyperthyroidism, endocrine tumors and extensive liver damage; 3. diagnosis of type 1 or type 2 diabetes per the judgment of the investigator; 4. current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), antidepressants, antipsychotic, mood stabilizers, antiepileptic and hormone contraceptive; 5. history of pancreatitis or pancreatectomy; 6. previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device; 7. current participation (or within the last month) in an organized weight reduction program or currently using or used medication for obesity or hyperglycemia within 3 months before screening: liraglutide, exenatide, pramlintide, orlistat, topiramate, phenteremine, or metformin (either by prescription or as part of a clinical trial); 8. a self-reported change in body weight \>5 kg within 3 months before screening irrespective of medical records; 9. serious medical conditions (including but not limited to ongoing renal or hepatic insufficiency, congestive heart failure, myocardial infarction, stroke, hematopoietic system diseases, progressive malignant tumor or other serious consumptive diseases); history of angina pectoris, transient ischemic attack, claudication, or acute limb ischemia within the past 6 months prior to screening; 10. serious psychiatric illness, including lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, and anorexia nervosa; current serious personality disorder, (e.g. borderline or antisocial), current severe major depressive disorder, recent (previous 6 months) suicide attempt or current active suicidal ideation, recent hospitalization due to psychiatric illness; 11. skin infection, blood coagulation disorders and other conditions that are not suitable for acupuncture; 12. metal allergies or severe fear of needles; 13. pregnant or breast-feeding women or planning to become pregnant during the study period; 14. any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol.

Keywords: acupuncture randomized controlled trial obesity pre-diabetes
in vitro human embryo culture system

Conditions: Infertility

Summary: the purpose of this study is to compare the development of human embryos grown in a conventional culture dish to those grown in a new embryo culture device known as the smart system.

this study is a multi-center, randomized, performance study.

Eligibility criteria:
inclusion criteria - all recruited subjects must meet all of the following inclusion criteria to be enrolled in the study: 1. female 21 to 35 years of age inclusive 2. first or second ivf cycle 3. not pregnant 4. no physical abnormalities that would adversely affect oocyte retrieval 5. male factor is acceptable 6. icsi is acceptable 7. 10 zygotes or more exclusion criteria- potential subjects are excluded from the study if any of the following conditions exist: 1. the sperm were retrieved using tese or mesa 2. the embryos were created with either donor oocytes or donor sperm. 3. medical condition precluding a safe pregnancy 4. medical condition disqualifying the subject from safely participating in the study in the judgment of the investigator

Keywords: infertility embryo development
safety and efficacy study of botulinum toxin type a to treat lower urinary symptoms due to benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin type a in treating lower urinary tract symptoms due to benign prostatic hyperplasia.


Eligibility criteria:
inclusion criteria: * lower urinary tract symptoms due to benign prostatic hyperplasia * enlarged prostate volume by rectal ultrasound exclusion criteria: * previous prostate surgery * previous or current diagnosis of prostate cancer * use of other medications for the treatment of prostatic hyperplasia * urinary tract infection
adjuvant treatment with abatacept to promote remission during peanut oral immunotherapy

Conditions: Peanut Allergy

Summary: this is a phase 2a, multi-center, randomized and double-blind placebo-controlled trial comparing 24 weeks of abatacept versus placebo used as adjuvant to oral immunotherapy to induce remission in adolescents and adults with persistent severe peanut allergy. this is a proof-of-concept trial in which the primary outcome will be the suppression of the initial peanut specific ige surge during oit, which is used as a proxy outcome of peanut allergy remission. adolescents and adults with persistent severe peanut allergy (n=14) will be randomized to either abatacept or placebo at a ratio 1:1 for a total period of 24 weeks. peanut oral immunotherapy will be initiated the day following the first administration of the investigational product. sustained tolerance to peanut will be assessed at 36 weeks.


Eligibility criteria:
inclusion criteria: * male or female subjects 14 to 50 years old at screening visit * history of ige mediated allergy to peanut protein * immunocap ige level \> 50 ku/l for peanut; * total ige level \< 5000 ku/l * willing to comply to all study requirements during participation in the study; exclusion criteria: * previous adverse reactions to abatacept; * known hypersensitivity to abatacept or any of its components; * patients at risk of sepsis, such as immunocompromised or hiv positive; * patient undergoing a treatment with any other biologic agent; * uncontrolled asthma; * unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation, administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease); * current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants or beta-blocker * concurrent/prior use of immunomodulatory therapy (within 6 months); * a diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic gastritis; * pregnant or breastfeeding women;

Keywords: peanut allergy abatacept oral immunotherapy
characterization of intestinal microbiota stability in preterm born neonates

Conditions: Necrotising Enterocolitis; Late-Onset Neonatal Sepsis

Summary: study around very-low birthweight preterm infants at high risk of developing necrotizing enterocolitis (nec) or late-onset sepsis (los). collection of stool and other biological samples to assess the strain-level stability of gastrointestinal microbiota in these preterm infants who may or may not develop nec/los.

this study aims to collect biological samples (stool, stomach fluid, and blood) from preterm infants at risk of developing nec or los; as well as environmental samples from infants' hospital surroundings (swabs, air), nutritional intake (formula, breastmilk) and samples from their family members (faeces, vaginal swab). the main focus of the study is to assess strain-level stability of gastrointestinal microbiota in these infants and potentially assess the source of disease-causing microbiota species/strains.

Eligibility criteria:
inclusion criteria: -preterm infants with a gestational age \< 32 weeks or a birthweight \< 1500g and their family members exclusion criteria: * intestinal atresia * live born infants referred to from other hospitals later than 3 days after birth
growth parameters & body mass index in children with chronic diseases

Conditions: Chronic Medical Diseases

Summary: deviations from the normal pattern of growth may be the first clues to pathology as in many chronic diseases evaluated clinically by anthropometric measurements \& body mass index. growth impairment in children with chronic diseases is associated with disruption of the growth hormone (gh) and predominantly results from undernutrition, chronic inflammation and prolonged corticosteroid treatment. undernutrition leads to major adaptations in the endocrine system towards conserving energy, diverting substrates away from growth and reproduction, and providing alternative sources of energy for critical body homeostasis. chronic inflammatory processes exacerbate undernutrition through proinflammatory cytokines such as interleukin-1\&6 and tumor necrosis factor. these growth-regulating mechanisms are disturbed further by corticosteroids used in some chronic conditions for their anti-inflammatory and immunosuppressive properties. growth impairment occurs with many chronic conditions e g: congenital heart dieases (chd), chronic pulmonary diseases such as bronchial asthma, gastrointestinal diseases sch as inflammatory bowel disease ,chronic liver diseases , chronic renal diseases, chronic hemolytic anemia and chronic central nervous system diseases.


Eligibility criteria:
inclusion criteria: * age: under 12 years old. * both sex . * patients with chronic medical diseases. exclusion criteria: * age: over 12years old. * patients with acute diseases. * pediatric with malignancy. * chronic patients with surgical sequelae.
prevalence of obstructive sleep apnea hypopnea syndrome (osahs) following squamous cell carcinomas of the oropharynx treatment by combined chemoradiotherapy

Conditions: Obstructive Sleep Apnea-hypopnea; Oropharyngeal Cancer

Summary: the study's aim is to determinate the prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy in a locally advanced stages treated population of oropharyngeal cancer. indeed, the level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor but the few studies published on the subject suggest an increased risk of development of osahs for these patients.


Eligibility criteria:
inclusion criteria: * age\> 18 years old * performance status 0-2 * squamous cell carcinoma of the oropharynx treated with concomitant chemoradiotherapy * treatment termination time greater than 6 months at inclusion * tumor classification (american joint committee on cancer 8th) t2-t4 n0-n3 * patient in complete remission at inclusion * patient's consent's obtained after information exclusion criteria: * previous treatment for upper aerodigestive tract cancer * incomplete radiotherapytreatment * neurological pathology wich may affect the functions of the upper aerodigestive tract * pregnant or breastfeeding woman * unweaned alcoholism * tracheotomized patient at the time of the study * patient under protection: subjects with guardianship or under law protection * no health insurance coverage

Keywords: combined chemoradiotherapy
routine ultrasound guidance for vascular access for cardiac procedures

Conditions: Myocardial Infarction; Coronary Artery Disease; Myocardial Ischemia

Summary: a randomized, controlled trial to determine whether the use of ultrasound guidance for vascular access during coronary angiography or percutaneous coronary intervention (pci) will reduce the rates of major vascular complications.

patients who will undergo a coronary angiography or pci using femoral access will be allocated to either: 1) femoral access using fluoroscopic and ultrasound guidance, or 2) femoral access using fluoroscopic guidance alone.

Eligibility criteria:
inclusion criteria: 1. patient referred for coronary angiography or percutaneous coronary intervention (pci) in whom femoral access is planned. 2. planned femoral access exclusion criteria: 1. age ≤ 18 years 2. stemi 3. absence of palpable femoral pulse